Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
LEVOFLOXACIN
Fresenius Kabi Limited
J01MA12
LEVOFLOXACIN
5 Mg/Ml
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Fluoroquinolones
Authorised
2009-07-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levofloxacin 5mg/ml solution for infusion, LDPE bottles 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 50 ML FILLED IN 100 ML BOTTLE: Each ml of solution for infusion contains 5 mg levofloxacin (as levofloxacin hemihydrate). 50 ml of solution for infusion contains 250 mg of levofloxacin as active substance. 100 ML FILLED IN 100 ML BOTTLE: Each ml of solution for infusion contains 5 mg levofloxacin (as levofloxacin hemihydrate). 100 ml of solution for infusion contains 500 mg of levofloxacin as active substance. Excipients: The medicinal product contains 3.5 mg of sodium per ml _For the full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Solution for infusion. Yellow to greenish yellow solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levofloxacin solution for infusion is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): Community-acquired pneumonia. Complicated skin and soft tissue infections. For the above-mentioned infections Levofloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections. Pyelonephritis and complicated urinary tract infections (see section 4.4) Chronic bacterial prostatitis Inhalation Anthrax: postexposure prophylaxis and curative treatment (see section 4.4). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Levofloxacin solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with Levo Les hele dokumentet